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Hospitals will have until Nov. 21 to complete the recertification process through the new Office of Pharmacy Affairs Information System.

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The harmful payment reduction was included in the 2018 Outpatient Prospective Payment System proposed rule, expected to be finalized this fall.

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The most recent delay to July 2018 comes after the Health Resources and Services Administration issued a proposed rule seeking feedback from stakeholders.

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Providers can register a new entity or contract pharmacy through the 340B Office of Pharmacy Affairs Information System through Oct. 16.

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The component enables manufacturers and covered entities to register for the 340B Drug Pricing Program, participate in annual recertification, and communicate with the Office of Pharmacy Affairs on pending tasks.

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A push is underway on Capitol Hill to delay Medicaid disproportionate share hospital cuts and withdraw proposed 340B policy. Please urge your member of Congress to sign both letters.

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Unless another delay is secured, Medicaid disproportionate share hospital payments will be cut by $2 billion beginning in fiscal year 2018, escalating to $8 billion by 2024.

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The Sept. 13 webinar for covered entities will focus on the registration component of the new Office of Pharmacy Affairs Information System.

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By cutting reimbursement rates for Part B drugs to 340B hospitals, the Centers for Medicare & Medicaid Services would harm essential hospitals, which care for the nation’s poorest, most complex, and costliest patients.

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The Health Resources and Services Administration is seeking comments on whether to further delay implementation of a final rule on ceiling prices and civil monetary penalties in the 340B Drug Pricing Program by nine months.

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The system will be unavailable from Aug. 15 until mid-September; hospitals are urged to verify contact information for authorizing officials and primary contacts in the system before Aug. 14.

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The delay allows for implementation of a new online tool that will allow providers to register and recertify 340B sites and contract pharmacies.

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Proposed rules would affect outpatient payment rates, reduce Medicare Part B payments to hospitals in the 340B Program, and revise site-neutral policies.

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The committee’s intentions remain unclear; we recommend essential hospitals prepare to publicly describe what auditors found and corrective actions taken.

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The final rule on drug ceiling prices and manufacturer civil monetary penalties under the 340B Drug Pricing Program now will go into effect on Oct. 1.

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HRSA has delayed until March 21 the effective date of a final rule on drug ceiling prices and manufacturer civil monetary penalties in the 340B program.

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The regulation makes "penny pricing" final and sets fines of up to $5,000 per instance of a manufacturer overcharging providers for covered medications in the 340B Drug Pricing Program.

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In this webinar we looked back at the 2016 advocacy landscape, discussed the progress we have made on key issues affecting essential hospitals, reviewed our interaction with the Trump transition team, and looked forward to 2017. Webinar Recording

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Congress passed a bill to fund the government through Dec. 9. Meanwhile, 179 House members sent a letter urging CMS to stop mandatory payment and service delivery demonstrations.

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Hospitals must complete recertification of their compliance with all requirements of the 340B program. Failure to do so results in removal from the program.

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HRSA is proposing that a decision-making body within the Department of Health and Human Services be responsible for reviewing claims and resolving deputes.

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The event, from 1 - 2 pm ET, will include important information on the annual recertification process and best practices.

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Senate appropriators pass HHS spending bill that includes 340B Drug Pricing Program user fee and instructions to HRSA to consider stakeholder input in final mega-guidance.

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The decision follows the pharmaceutical company's recent recalculation of 340B ceiling prices for 25 products for the third quarter of 2012 through the second quarter of 2013.

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In new Modern Healthcare commentary, America's Essential Hospitals president and CEO says proposed guidance conflicts with HHS goals for readmissions, access, and care coordination.

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A 2015 budget law that creates site-neutral payment for off-campus hospital outpatient departments does not directly affect 340B Drug Pricing Program eligibility, but changes to how hospitals report Medicare costs does raise concerns.

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Proposed regulations would dramatically narrow access to 340B, harming vulnerable patients and putting entire communities at risk of losing vital services.

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Final rule and implementation as described in the guidance could significantly reduce Medicaid payments for 340B-covered outpatient drugs in some states.

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Webcasts, co-hosted by HRSA OPA and pharmacist association, will focus on helping covered entities identify steps needed to develop and maintain comprehensive 340B policies and procedures in an auditable manner.

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House, Senate panels to examine rising cost of drugs, lack of transparency in the drug price negotiation process, and barriers to generic drug applications.

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America's Essential Hospitals and two members systems host congressional staff for round-table discussions about how proposed 340B Drug Pricing Program guidance threatens vulnerable patients and essential hospitals.

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Covered entities are no longer required to post a public letter to the HRSA website if 340B audit findings result in potential repayment. Instead, HRSA will publish notices with covered entity contact information.

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Agency seeks comment on its proposal to collect information on the burden associated with guidelines for manufacturer audits of covered entities; comments are due to HRSA by Feb. 22.

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Member leaders attend more than 100 meetings with lawmakers and congressional staff as part of fall Policy Assembly. Event also included insights from policymakers and a Capitol Hill reception honoring 2015 Gage Award recipients.

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In comments to HRSA, association touches on restrictive patient definition, outpatient facility eligibility, and limits on qualifying drugs

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U.S. District Court says 2014 HRSA interpretive rule is contrary to plain language of ACA provision that excludes certain hospitals from 340B discounts on orphan drugs.

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Webinars help identify roles, responsibilities, and other 340B risk management elements, OPA and APhA also accepting leading practice site applications

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Zydus Pharmaceuticals Inc., charged incorrect rates on 340B drugs between January 2012 and December 2014, refunds will be distributed via Apexus

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Heritage Pharmaceuticals Inc., charged incorrect rates on 340B drugs between April 18, 2008 and Dec. 31, 2014, refunds are available

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Proposed changes could significantly narrow the scope of patients for whom 340B pricing may be utilized and reduce potential savings from program

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Omnibus guidance proposes an expanded list of six requirements for an individual to be considered a patient of a 340B covered entity.

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Participants learned about HRSA's guidance on the 340B Drug Pricing Program and how it will affect their hospital.

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Failure to recertify will result in removal from program, hospitals should have already received information from federal government needed to complete process.

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Report suggests financial incentive for hospitals to prescribe 340B drugs, a claim America's Essential Hospitals calls unfounded and troubling.

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Hospitals and covered entities currently enrolled in the 340B Drug Pricing Program are invited to a July 8 webinar to discuss the annual recertification process. The meeting will be hosted by the Office of Pharmacy Affairs (OPA), which is part of the Health Resources and Services Administration (HRSA). Hospitals are required to annually recertify that

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Proposed rule also calls for increased transparency in ceiling price calculation, separate guidance to replace mega reg

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Parts of the Cures package will now likely go to other House committees for review

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We look forward to working with lawmakers to strengthen the 340B program in the future

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It remains unclear what 340B Drug Pricing Program provisions could be included in the legislation

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Energy and Commerce will vote on 21st Century Cures Wednesday; a 340B amendment may be included.

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The association is pleased the Committee on Energy and Commerce is working collaboratively with stakeholders.

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Letter emphasizes value of program to vulnerable patients and hospitals, and risk of harming care by limiting program access

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For now, lawmakers focused on information gathering, better oversight, clarity, and accountability

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Contact your lawmakers on the House Energy and Commerce and Senate Health, Education, Labor, and Pensions committees to underscore the critical need for the 340B program.

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Learn more about association and member efforts to defend the 340B Drug Pricing Program

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Commentary argues to keep program savings with essential hospitals to benefit low-income patients and entire communities

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HRSA had submitted a 340B proposed rule to OMB, but a subsequent court ruling questioned the agency's authority to issue a rule

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Latest critique of 340B disappoints with fiction and unsupported assertions, rather than the plain facts of this important program

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Webinar will cover recent changes to audit process; OPA also working to standardize process for self-disclosing a 340B requirement breach

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The lawsuit would challenge OPA's interpretative rule implementing the orphan drug provision for new 340B covered entities under the ACA

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OPA notify hospitals via email of the need to recertify for eligibility for the 340B program.

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These members of Congress went on record supporting the 340B Drug Pricing Program and the patients it benefits.

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New interpretive rule will address the 340B orphan drug exclusion.

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In particular, OPA has changed the process for correcting or addressing findings on which covered entities and auditors disagree.

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HRSA stands by its interpretation of the 340B orphan drug rule

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The regulations provide guidance for the AIDS Drug Assistance Program and the National Hemophilia Program

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The U.S. District Court for the District of Columbia vacated HHS' final rule on orphan drug pricing and granted an injunction that prevents HHS from implementing the rule.

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The webinar will be held June 9 at 2 pm ET.

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Stakeholders will discuss several 340B policy matters including the forthcoming mega-reg.

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Discussions included hospital eligibility in 340B, the definition of a patient at 340B-eligible hospitals, and contract pharmacies

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Senate Democrats sent a letter to OMB and HRSA supporting the 340B program, appropriations committees begin their markup processes

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Lawmakers in both the House and Senate introduced a consensus bill to repeal the Medicare physician payment system, which is partially based on the sustainable growth rate

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The OIG gathered information from a sample of covered entities to learn about their contract pharmacy arrangements.

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Association, two other national organizations file amicus brief in support of HRSA interpretation of law

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Analysis finds program is likely to grow in states expanding their Medicaid program

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Failure to complete recertification could result in dismissal from program

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All 340B authorizing officials expected to receive access to complete process by email

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Separate physical inventories not required for compliance with group purchasing organization prohibition guidance

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Senator's letter requests specific information about 340B covered entities

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Certain providers may receive drug discounts for uses outside indication associated with orphan designation

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On law's 20th anniversary, members of Congress say law helps reduce drug costs for hundreds of hospital

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President and CEO Bruce Siegel focused on program's benefits to patients and the hospitals on which they depend

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Hospitals urged to review language on certification of compliance with group purchasing organization guidance

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Deadline extended after significant pressure from America's Essential Hospitals and association members

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About America’s Essential Hospitals

America’s Essential Hospitals is the leading association and champion for hospitals and health systems dedicated to high-quality care for all, including the most vulnerable. Since 1981, America’s Essential Hospitals has initiated, advanced, and preserved programs and policies that help these hospitals ensure access to care. We support members with advocacy, policy development, research, and education.